Board orders survey on compounding practices

Florida pharmacy regulators issued an emergency order Tuesday requiring Florida's more than 7,700 pharmacies to complete a survey about their compounding practices.

By Fred HiersStaff writer

Florida pharmacy regulators issued an emergency order Tuesday requiring Florida's more than 7,700 pharmacies to complete a survey about their compounding practices.The move comes in the midst of a fungal meningitis outbreak linked to pain medications prepared by a Boston-area compounding pharmacy. The outbreak has shined a harsh light on compounding, which is the practice by pharmacies of creating specialized medicines and sterile substances to sell to patients with prescriptions.The Florida Department of Health had tried to gather information about pharmacies' compounding practices through a voluntary survey, but officials said 90 percent of pharmacists did not respond.Board of Pharmacy members said they have little information about the extent to which Florida pharmacies make their own drugs, how much they make and how much of it is sent out of the state. They said the mandatory survey was an attempt to get a handle on the issue. The Pharmacy Board is part of the Florida Department of Health.The recent meningitis outbreak was traced to contaminated lots of methylprednisolone acetate from the New England Compounding Center (NECC) in Massachusetts. The pain medication has sickened nearly 500 people across 19 states and left 33 dead, including three in Florida.There are 24 confirmed cases so far in Florida, most of them in Marion County, where three medical facilities used the contaminated drugs.Although Florida has laws governing medicine manufactured by pharmacies, Pharmacy Board members concluded that the mandatory survey was a first, short-term step by regulators to learn more about the industry."We really don't know where we stand with compounding pharmacies," said Pharmacy Board member Albert Garcia following the mandatory survey vote Tuesday in Orlando.What is known is that many pharmacists make their own medicines.The Florida Department of Health concluded that as of July 1, nearly 18 percent of the 2,075 pharmacies that were inspected were compounding. Inspectors don't know, however, what those pharmacies are making or how much they are making.Cassandra Pasley, a Florida Department of Health official, told the board it was important that Florida knew how many pharmacists made non-sterile and sterile medications and the survey, although not perfect, at least gave a "snapshot" of compounding in Florida.She said the goal wasn't to punish compounding pharmacies with the survey, but to gather information.Pharmacy Board member Leo Fallon said regulators had little option but to make the survey mandatory.As for the lack of DOH knowledge about compounding in Florida, Fallon said he wasn't surprised, given the lack of permitting required for pharmacists to make medicine.But Michael Jackson, executive vice president and CEO of the Florida Pharmacy Association, said some of the questions in the survey could create problems.Florida needs to know which pharmacies are making drugs, but other survey questions could lead to punishment or investigations of pharmacies, Jackson said.He said that if the survey focuses on collecting generalized compounding information, pharmacies would be more likely to be honest with their responses, he said.The new survey rule goes into effect 14 days after the Florida Department of Agriculture and Consumer Services signs off on the regulations.Pharmacy Board members also agreed to consider making Florida pharmacists who compound medicines meet accreditation standards."For sterile compounding, accreditation is a must," said Pharmacy Board member Garcia.Compounding pharmacies make medications and other medical preparations from scratch. They cannot make copies of commercially available medications and can make medications only when they are ordered by a doctor. Most make uniquely formulated medicines for patients who cannot take a commercially produced brand.In recent years, however, some pharmacies have started mass producing drugs, especially medicines for which there are otherwise shortages.Currently, licensed Florida pharmacists are allowed to compound medications without any accreditation. Pharmacists making non-sterile medicines encounter minimal inspections while those making sterile medicines for injection purposes — such as the contaminated medicines behind the outbreak — require a higher level of regulation, said pharmacists who attended the meeting.Garcia said requiring accreditation in Florida may influence pharmacists in other states to do the same. At the very least, Garcia said, the requirement of accreditation would create an additional layer to provide the public with more safety against contaminated drugs.But accreditation of Florida compounding pharmacies would not protect consumers against drugs made out of state. Florida law allows compounding pharmacies based in other states to do business here as long as they comply with the compounding laws of their own states.That limits the Pharmacy Board's regulatory power over those pharmacies, Pharmacy Board lawyer David Flynn told regulators.In the case of NECC, the Massachusetts company made 17,000 doses, and was licensed to ship its medication to Florida. After the outbreak, federal and state inspections of the NECC facility noted unclean working conditions where the contaminated medicine was manufactured. An investigation of its inspection records also showed a lack of enforcement following prior inspection violations.The Food and Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight of compounding pharmacies because of the way the law establishing the agency was drawn up in the 1930s. Each state regulates compounders and pharmacists, but oversight and regulations differ from state to state. The FDA traditionally focuses on large-scale drug manufacturers.Brian Kahan, a lawyer representing 100 compounding pharmacies, said current laws and regulations are sufficient, as long as they are enforced. No new accreditation is necessary, he said.He told the board that the call for additional accreditation "sounds really good" but that he didn't think it would protect the public any more.Boca Raton pharmacist Angela Mann said during a break in the meeting that accreditation — especially imposed by each state — would be too costly.Contact Fred Hiers at 867-4157 or fred.hiers@starbanner.com.